510(k) · Cleared
ClearedElectronic House Call
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Express MD Solutions, LLC · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Apr 8, 2009 as substantially equivalent to K993128 (Health Hero Network, Inc., 1999) and 10 other predicates after a 15-day review. Its family tree reaches back 10 generations to 1987. 1 of the 73 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Apr 8, 2009
- Review
- 15 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 10 generations to K864318 (1987). 69 ancestors in all, the oldest K790130 (1979). 3 later devices descend from it, 2 citing it directly. 1 of the 73 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 6 generations between
- 3 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 2 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 1 generation backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- This deviceK090801 Electronic House CallExpress MD Solutions, LLC · 2009
- Descendant · cites it directly · 1 of its ownK102063 Health-E-Connect SystemAlr Technologies · 2011
- Descendant · 2 generations on · 0 of its ownK163664 Health-e-Connect System with IDAAlr Technologies · 2017
- Descendant · cites it directly · 0 of its ownK093895 Ally Platform SystemContinuity Health Solutions · 2010
Show all 10 generations
- Root · 10 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 9 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 8 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 7 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 6 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 5 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 4 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 3 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 2 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 1 generation backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- This deviceK090801 Electronic House CallExpress MD Solutions, LLC · 2009
Class I recalls in this family
- K022732 Infant/Child Reduced Energy Electrodes3 generations back · 2002
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −9 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −8 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −7 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −6 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −5 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −4 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −3 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −2 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −1 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| 0 (this device) | K090801 | Electronic House Call | Express MD Solutions, LLC | 2009 | — |
| +1 | K102063 | Health-E-Connect System | Alr Technologies | 2011 | — |
| +2 | K163664 | Health-e-Connect System with IDA | Alr Technologies | 2017 | — |
| +1 | K093895 | Ally Platform System | Continuity Health Solutions | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 9 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 1 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (11)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K993128 | Healthbuddy with Device Connect [Glucose Meter]Summary page 1…ehealth System Classification Name: Physiological Signal Transmitters and Receivers 3. PREDICATE DEVICES * Health Buddy with Glucose Connectivity (K993128) • Health Buddy with BuddyLink (K040086) * Health Buddy with Device Connectivity(K042273) * Health Buddy App… | 1999 |
| * | K040086 | Health Buddy with BuddylinkSummary page 1…Physiological Signal Transmitters and Receivers 3. PREDICATE DEVICES * Health Buddy with Glucose Connectivity (K993128) • Health Buddy with BuddyLink (K040086) * Health Buddy with Device Connectivity(K042273) * Health Buddy Appliance (K050567) * Health Buddy Applianc… | 2004 |
| * | K042273 | Modification to Health Buddy with Device ConnectivitySummary page 1…REDICATE DEVICES * Health Buddy with Glucose Connectivity (K993128) • Health Buddy with BuddyLink (K040086) * Health Buddy with Device Connectivity(K042273) * Health Buddy Appliance (K050567) * Health Buddy Appliance, Health Hero Network (K060843) * Neptec Care Co… | 2004 |
| * | K050567 | Health Buddy ApplianceSummary page 1…th Glucose Connectivity (K993128) • Health Buddy with BuddyLink (K040086) * Health Buddy with Device Connectivity(K042273) * Health Buddy Appliance (K050567) * Health Buddy Appliance, Health Hero Network (K060843) * Neptec Care Companion Nurse and Patient Station K022274… | 2005 |
| * | K060843 | Modification to Health Buddy ApplianceSummary page 1…ddyLink (K040086) * Health Buddy with Device Connectivity(K042273) * Health Buddy Appliance (K050567) * Health Buddy Appliance, Health Hero Network (K060843) * Neptec Care Companion Nurse and Patient Station K022274 and K023286 * RTX DLM1 12 Daylink Monitor (K062304)… | 2006 |
| * | K022274 | Carecompanion Patient Station & Nurse StationSummary page 1…042273) * Health Buddy Appliance (K050567) * Health Buddy Appliance, Health Hero Network (K060843) * Neptec Care Companion Nurse and Patient Station K022274 and K023286 * RTX DLM1 12 Daylink Monitor (K062304) * ZOLL M-Series NIBP Option (K032363) * ZOLL E-Series NI… | 2003 |
| * | K023286 | Carecompanion Patient Station/Carecompanion Patient StationSummary page 1…* Health Buddy Appliance (K050567) * Health Buddy Appliance, Health Hero Network (K060843) * Neptec Care Companion Nurse and Patient Station K022274 and K023286 * RTX DLM1 12 Daylink Monitor (K062304) * ZOLL M-Series NIBP Option (K032363) * ZOLL E-Series NIBP Option (K… | 2003 |
| * | K062304 | DLM112 Daylink MonitorSummary page 1…Health Buddy Appliance, Health Hero Network (K060843) * Neptec Care Companion Nurse and Patient Station K022274 and K023286 * RTX DLM1 12 Daylink Monitor (K062304) * ZOLL M-Series NIBP Option (K032363) * ZOLL E-Series NIBP Option (K042007) * March Healthcare HMIK (K06019… | 2006 |
| * | K032363 | Zoll M Series Nibp OptionSummary page 1…(K060843) * Neptec Care Companion Nurse and Patient Station K022274 and K023286 * RTX DLM1 12 Daylink Monitor (K062304) * ZOLL M-Series NIBP Option (K032363) * ZOLL E-Series NIBP Option (K042007) * March Healthcare HMIK (K060194) 4. DEVICE DESCRIPTION The Express… | 2003 |
| * | K042007 | Zoll E Series DefibrillatorSummary page 1…e and Patient Station K022274 and K023286 * RTX DLM1 12 Daylink Monitor (K062304) * ZOLL M-Series NIBP Option (K032363) * ZOLL E-Series NIBP Option (K042007) * March Healthcare HMIK (K060194) 4. DEVICE DESCRIPTION The Express MD Electronic House CalTM System is comprise… | 2005 |
| * | K060194 | March Healthcare Health Monitoring KitSummary page 1…* RTX DLM1 12 Daylink Monitor (K062304) * ZOLL M-Series NIBP Option (K032363) * ZOLL E-Series NIBP Option (K042007) * March Healthcare HMIK (K060194) 4. DEVICE DESCRIPTION The Express MD Electronic House CalTM System is comprised of a home unit, legally marketed d… | 2006 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · 3 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 22 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 10 of the 69 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K102063 (Alr Technologies, 2011) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K993128.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Electronic House Call System (Electronic House Call Device + Electronic House Call Application + Electronic House Call Website) is a remote, retrospective monitoring tool for supplement in a patients' care. The Electronic House Call Device together with the Electronic House Call Application is intended to be a simple "store and forward" communications platform that allows clinicians and privileged users to access a patients' imforiation for review…
Read the full statement (155 words)
The Electronic House Call System (Electronic House Call Device + Electronic House Call Application + Electronic House Call Website) is a remote, retrospective monitoring tool for supplement in a patients' care. The Electronic House Call Device together with the Electronic House Call Application is intended to be a simple "store and forward" communications platform that allows clinicians and privileged users to access a patients' imforiation for review through the Electronic House Call Website. The Electronic House Call Device is a tool to monitor patients' remotely and motivate them through education and reminders. The Electronic House Call System allows patients to measure vital signs without assistance from their healthcare provider. The Electronic House Call System is not intended to replace existing treatments or consultations, nor is it to be used as a substitute for a qualified healthcare professional's judgment/treatment plan. The Electronic House Call System is also not intended to act as an emergency response system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090801: Electronic House Call.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090801
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026